Cleared Traditional

VariTrax Sternal CircumFixation System

K232986 · Circumfix Solutions, Inc. · Orthopedic

Jan 2024

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K232986 is an FDA 510(k) clearance for the VariTrax Sternal CircumFixation System, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Circumfix Solutions, Inc. (Collierville, US). The FDA issued a Cleared decision on January 30, 2024, 130 days after receiving the submission on September 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K232986 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2023
Decision Date	January 30, 2024
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF